Flake Alan W, De Bie Felix R, Munson David A, Feudtner Chris
Department of Surgery, Center for Fetal Research, Children's Hospital of Philadelphia, Department of Surgery, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Division of Neonatology, Children's Hospital of Philadelphia, Department of Pediatrics, Perelman School of Medicine, Universityof Pennsylvania, Philadelphia, PA, USA.
J Perinatol. 2023 Nov;43(11):1343-1348. doi: 10.1038/s41372-023-01716-2. Epub 2023 Jul 1.
The so called "Artificial Placenta" and "Artificial Womb" (EXTEND) technologies share a common goal of improving outcomes for extreme premature infants. Beyond that goal, they are very dissimilar and, in our view, differ sufficiently in their technology, intervention strategy, demonstrated physiology, and risk profiles that bundling them together for consideration of the ethical challenges in designing first in human trials is misguided. In this response to the commentary by Kukora and colleagues, we will provide our perspective on these differences, and how they impact ethical clinical study design for first-in-human trials of safety/feasibility, and subsequently efficacy of the two technologies.
所谓的“人工胎盘”和“人工子宫”(EXTEND)技术有着共同的目标,即改善极早产儿的预后。除了这个目标之外,它们差异很大,而且在我们看来,它们在技术、干预策略、已证实的生理学以及风险概况方面存在足够的差异,将它们捆绑在一起以考虑首次人体试验设计中的伦理挑战是错误的。在对库科拉及其同事评论的回应中,我们将阐述我们对这些差异的看法,以及它们如何影响这两种技术首次人体安全性/可行性试验以及后续疗效试验的伦理临床研究设计。